APO-PERINDOPRIL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PERINDOPRIL ERBUMINE

Disponible des:

APOTEX INC

Codi ATC:

C09AA04

Designació comuna internacional (DCI):

PERINDOPRIL

Dosis:

2MG

formulario farmacéutico:

TABLET

Composición:

PERINDOPRIL ERBUMINE 2MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0127178001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-03-07

Fitxa tècnica

_APO-PERINDOPRIL (Perindopril erbumine tablets) _
_Page 1 of 75_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-PERINDOPRIL
Perindopril erbumine tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
Apotex Standard
Angiotensin Converting Enzyme Inhibitor
Submission Control Number: 272361
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 07, 2018
Date of Revision:
AUG 01, 2023
_APO-PERINDOPRIL (Perindopril erbumine tablets) _
_Page 2 of 75_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNING AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics (< 18 years of age)
.............................................................................
4
1.2
Geriatrics (>65 years of age)
...............................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 5
4
DOSAGE AND
ADMINISTRATION...............................................................................
5
4.1
Dosing Considerations
........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 6
4.4
Administration
................................................................................